Bladder Cancer Recurrence Clinical Trial
Official title:
Phase 3 Study of Bladder Cancer Recurrence Surveillance
| Verified date | November 2009 |
| Source | Predictive Biosciences |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Observational |
The purpose of this study is to detect recurrent bladder cancer using a combination of protein and DNA biomarkers in urine
| Status | Completed |
| Enrollment | 1000 |
| Est. completion date | October 2010 |
| Est. primary completion date | April 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Intact bladder - Scheduled for cystoscopy for transitional cell bladder cancer recurrence screening - Urine donated prior to cystoscopy, Bladder biopsy, chemotherapy, intravesical therapy, radiation or TUR - Must be willing to sign IRB approved informed consent Exclusion Criteria: - History or current diagnosis of any cancer except transitional cell bladder cancer or basal cell cancer - Known diagnosis of any autoimmune disease or HIV, HCV or HBV - History or current TB or any other active infection - Subject has gross hematuria - Receiving chemotherapy, intravesical therapy or radiation within 30 days of enrollment - Any surgery except urologic within past 30 days |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| United States | Associates in Urology/Urology Group of NJ | 741 Northfield Avenue | New Jersey |
| United States | Capital Regional Urological Surgeons | Albany | New York |
| United States | Community Care Physicians | Albany | New York |
| United States | Coastal Urology Associates | Brick | New Jersey |
| United States | The Urology Group | Cincinnati | Ohio |
| United States | Urology Clinics of North Texas | Dallas | Texas |
| United States | Atlantic Urological Associates | Daytona Beach | Florida |
| United States | Urology Associates | Engelwood | Colorado |
| United States | Metropolitan Urology | Jeffersonville | Indiana |
| United States | Urological Associates of Lancaster | Lancaster | Pennsylvania |
| United States | Carolina Urologic Research Center | Myrtle Beach | South Carolina |
| United States | University Urology Associates | New York | New York |
| United States | Winter Park Urology | Orlando | Florida |
| United States | BCG Oncology | Phoenix | Arizona |
| United States | Triangle Urologic Group | Pittsburgh | Pennsylvania |
| United States | Hudson Valley Urology | Poughkeepsie | New York |
| United States | Mayo Validation Support Services | Rochester | Minnesota |
| United States | Urology San Antonio Research | San Antonio | Texas |
| United States | Associated Medical Professionals | Syracuse | New York |
| United States | Metro Urology | Woodbury | Minnesota |
| Lead Sponsor | Collaborator |
|---|---|
| Predictive Biosciences |
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